Brand Name | AXONICS |
Type of Device | NEUROSTIMULATOR |
Manufacturer (Section D) |
AXONICS, INC. |
26 technology dr |
irvine CA 92618 |
|
Manufacturer Contact |
james
nguyen
|
26 technology dr |
irvine, CA 92618
|
|
MDR Report Key | 18793126 |
MDR Text Key | 336397643 |
Report Number | 3002968685-2024-00033 |
Device Sequence Number | 1 |
Product Code |
EZW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P180046 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/29/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | 1201 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/16/2024 |
Initial Date FDA Received | 02/27/2024 |
Supplement Dates Manufacturer Received | 02/16/2024
|
Supplement Dates FDA Received | 03/29/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/19/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 69 YR |
|
|